Kornimate/medical-research-clean huggingface dataset:
a study of omp-336b11 in subjects with locally advanced or metastatic tumors

Conditions: Locally Advanced Malignant Neoplasm; Metastatic Cancer

Summary: the purpose of this study is to test the safety and efficacy of omp-336b11. omp-336b11 is an engineered human protein that was designed to bind to the gitr receptor on t cells and activate the immune system to recognize and eliminate cancer cells.

this is an open-label, phase 1a dose escalation study of omp-336b11 administered as a single agent to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with locally advanced or metastatic tumors. this study consists of a screening period, a treatment period, and a post-treatment follow-up period in which patients will be followed for survival for up to approximately 2 years. patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.

Eligibility criteria:
inclusion criteria: * locally advanced or metastatic solid tumors that have exhausted standard of care therapy * measurable disease per response evaluation criteria in solid tumors (recist) v1.1 * age \>21 years * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate organ and marrow function * for women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit. * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * receiving any other investigational agents or any other anti-cancer therapy * active autoimmune disease or a history of severe autoimmune disease or syndrome * history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * pregnancy, lactating or breastfeeding women * history of primary cns malignancy, or leptomeningeal disease or cns metastases * significant uncontrolled intercurrent illness that will limit the patient's ability to participate in the study * inability to comply with study and follow up procedures
effects of transcutaneous electrical diaphragmatic stimulation on respiratory variables in copd patients

Conditions: COPD

Summary: transcutaneous electrical diaphragmatic stimulation (teds) has been used to improve respiratory muscle strength in patients with respiratory muscles weakness. however, this physiotherapeutic resource has not been studied in chronic obstructive pulmonary disease (copd) yet. the objective of this study is to evaluate the respiratory pattern during the session of teds besides its effect in respiratory muscle strength and in spirometric variables as much healthy patients as in copd patients. methods: healthy and copd patients are selected and submitted to teds treatment. the plethysmographic analysis (lifeshirt system - vivometric), respiratory muscle strength and spirometry will be made. the hypothesis is that the teds can helps copd patients that shows respiratory muscle weakness.


Eligibility criteria:
inclusion criteria: * patients with stable copd (diagnosed by accepted criteria) * healthy patients exclusion criteria: * for the copd patients: * over 80 years of age * history of recent exacerbation * patients with pacemakers * uncontrolled arterial hypertension * requiring home oxygen therapy. * for the healthy patients: * pulmonary diseases * cardiovascular diseases * orthopedic diseases * neurologic diseases.

Keywords: chronic obstructive pulmonary disease diaphragm electrical stimulation pulmonary rehabilitation
a study of 2 doses of map0010 in adult asthmatics

Conditions: Asthma

Summary: the purpose of this study is to examine the blood levels of two doses of map0010 (a corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with twice daily dosing over 7 days.


Eligibility criteria:
inclusion criteria: * male or female adult asthmatics with mild to moderate persistent asthma. * 18 to 45 (up to the 46th birthday) years of age. * documented diagnosis of asthma at least 3 months prior to visit 1, per nih/nhlbi, epr-3 criteria. * able to withhold short-acting bronchodilators (e.g., albuterol or ipratropium bromide) for at least 4 hours prior to clinic visits. * baseline fev1 greater than or equal to 50% of predicted normal. exclusion criteria: * any other significant illness/abnormality * a history of upper or lower respiratory tract infection within 2 weeks * a history of acute or severe asthma attack requiring icu admission or ventilatory support.

Keywords: adult asthmatics
vandetanib risk minimisation effectiveness

Conditions: Medullary Thyroid Cancer

Summary: effectiveness of risk minimisation interventions for vandetanib in canada

as part of the new drug approval process in canada, astrazeneca has committed to health canada to conduct a drug utilization study among patients recently treated with caprelsa (vandetanib) and a knowledge and understanding survey among the prescribing physicians to determine whether the product monograph, communication plan, and educational material developed by astrazeneca canada for vandetanib are adequate to provide knowledge about the potential risks associated with this product, and if other medications taken concomitantly with vandetanib are managed adequately.

Eligibility criteria:
inclusion criteria: - n/a (all patients taking caprelsa and all prescribers will be contacted for participation). exclusion criteria: - n/a

Keywords: effectiveness of risk mitigation, knowledge and understanding survey, drug utilisation study, post marketing commitments
management of acute myocardial infarction in the presence of left bundle branch block

Conditions: Acute Coronary Syndrome

Summary: the primary objective of this study is to propose new treatment algorithm (strategy) for patients with acute coronary syndrome (acs) and left bundle-branch block (lbbb).

current recommendations on the treatment of acute coronary syndrome (acs) dictate urgent reperfusion therapy in the case of evolving myocardial infarction with st-segment elevation (stemi). optimal use of pci (preferably) or thrombolysis in this situation requires a rapid and correct diagnosis. according to the esc'2008 and acc/aha'2009 focused update guidelines patients admitted to the hospital within 12 hours after the onset of chest pain with new (or presumably new) left bundle-branch block (lbbb) should be treated like patients having stemi (class i, level a). however, it is well-known that in patients with concomitant lbbb, the ecg manifestations of acute myocardial injury may be masked. acs may occur in a patient with "true old" lbbb (when doctor has/has not an ability to compare the new ecg with the previous one) or (presumably) new lbbb. there is a high risk of non receiving appropriate therapy or of receiving inappropriate therapy (thrombolysis instead of lmwh/ufh/fondaparinux).

Eligibility criteria:
inclusion criteria: * age 18 - 75 years * ischemic discomfort (ie, ischemic chest pain or equivalent) at rest ≥20 minutes within previous 24 hours. * any (new, presumably new, or old) lbbb on the prehospital (ambulance) or admission ecg. * urgent coronary angiography (followed, when indicated, by pci), ideally within 90 minutes after admission exclusion criteria: * all-comers design

Keywords: acute coronary syndrome percutaneous coronary intervention left bundle branch block
point of care ultrasound for the detection of esophageal food bolus

Conditions: Esophageal Foreign Body; Esophageal Obstruction

Summary: this will be a prospective, observational, case-control study of adult patients presenting to the wellspan york hospital emergency department (yhed) with signs and symptoms of esophageal food or foreign body impaction. point of care ultrasound (pocus) will then be performed by a trained emergency physician to collect ultrasound data, including the presence or absence of direct visualization food bolus/foreign body, as well as secondary markers of dilatation, such as maximal esophageal area. investigators will also enroll an age/sex-matched control group of asymptomatic individuals to establish baseline esophageal measurements. patients will otherwise receive medical treatment per standard of care. subsequent interventions will also be documented, including glucagon, carbonated beverages, and esophagogastroduodenoscopy (egd). if patients remain in the ed and improve without need for egd they will undergo repeat ultrasound. chart review at 1 month will be performed to establish results of egd including improvement, recurrence, or presence of pathologic abnormalities. the investigators aim to establish normal and abnormal parameters to aid in the diagnosis of esophageal food impactions to predict need for definitive egd management.


Eligibility criteria:
eligibility (cases) * inclusion criteria: 1. age ≥18 years 2. signs and symptoms of esophageal food bolus or foreign body * exclusion criteria: 1. prior esophageal surgery 2. history of head/neck cancer 3. incarcerated individuals 4. individuals unable to provide consent 5. clinical instability or airway compromise eligibility (controls) * inclusion criteria: 1. age ≥18 years 2. no signs or symptoms of esophageal food bolus or foreign body 3. age/sex match to previously enrolled case subject * exclusion criteria: 1. prior esophageal surgery/dilation/pathology 2. history of head/neck cancer 3. incarcerated individuals 4. individuals unable to provide consent 5. clinical instability or airway compromise 6. presentation involving any of the following symptoms: * nausea/vomiting * diarrhea * abdominal pain * chest pain * shortness of breath * dysphagia/odynophagia * cough
the effect of aromatase inhibitors on cardiovascular risk factors in women with breast cancer

Conditions: Breast Cancer

Summary: this study explores how aromatase inhibitor therapy affects risk factors for heart disease in postmenopausal women with breast cancer.


Eligibility criteria:
inclusion criteria: * ambulatory women (aged 60-75), with a new diagnosis of nonmetastatic, hormone-receptor positive breast cancer, having undergone lumpectomy. they will not need chemotherapy and will have been prescribed but not yet started anastrazole. all will need a course of radiation therapy as part of usual care. participants are instructed not to change their physical activity or eating habits over the period of the study. comparisons are: * identical to the cases except they are hormone-receptor negative and don't need hormonal therapy. * healthy controls. exclusion criteria: * nicotine usage * metastatic breast cancer * need for chemotherapy * ai other than anastrazole * usage of steroids (equivalent of equal then or more than 7.5 mg prednisone x 3 months) * clinically significant abnormality of thyroid function * treatment with gonadal hormone replacement therapy within last 3 years * status post unilateral/bilateral surgical oophorectomy * having experienced a medical event, which may confound study outcomes \[e.g. heart attack, stroke, cancer (metastatic or newly diagnosed within last 5 years, except for non-melanoma skin cancer and breast), lupus, rheumatoid arthritis, chronic inflammatory disease\] * medication-dependent diabetes mellitus or hypercholesterolemia. * gastric surgery * weight loss medication (prescription or over the counter)

Keywords: aromatase inhibitor anastrazole arimidex heart disease lipids body composition breast cancer.
scad : a registry of spontaneous coronary artery dissection

Conditions: Spontaneous Coronary Artery Dissection

Summary: spontaneous coronary artery dissection (scad) is an increasingly recognised cause of non-atherosclerotic acute coronary syndromes (acs), predominantly afflicting young women without conventional atherosclerotic risk factors. knowledge of scad has advanced considerably in the last few years as a result of data from a number of local and national registries 1-6. like all rarer diseases however, a better understanding of scad will require international collaboration. at present, there is no european or international scad registry despite increasing recognition that there are key differences in the diagnosis, interventional and medical management of scad compared with conventional atherosclerotic acs. the esc-acca study group on spontaneous coronary artery dissection supported by the european observational research programme will now build the first pan-european scad registry to advance our understanding of current management of this condition, inform guidelines, educate clinical colleagues and advance research.

observational, multicentre, international retrospective and prospective cohort study. since this is an observational study, a formal sample size is not necessary. at least 500 prospectively recruited patients and 500 historical cases will be enrolled. patient data will be collected at the following time-points: * first scad event visit (retrospectively on chart review) * first follow-up: at time of enrolment * yearly follow-up: up to 1, 2, 3, 4 and 5 years post enrolment or until study completion approximately 30 countries and 120 sites will participate in this registry.

Eligibility criteria:
inclusion criteria: * patient having signed an informed consent * patient aged 18 years and over * scad clinical diagnosis within the past 10 years and available coronary angiographic imagery exclusion criteria: * patient unwilling or unable to consent * patients with iatrogenic or atherosclerotic coronary dissection
de novo sirolimus-based immunosuppression after liver transplantation for hepatocellular carcinoma

Conditions: Liver Carcinoma

Summary: this study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.

a total of 70 patients with hcc (mean age: 54.6 years, female/male: 12/58) received a liver transplant and were included in the study. immunosuppression included de novo sirolimus, low-dose calcineurin inhibitor for 6 to 12 months, with short-course (3 months) or no steroids.

Eligibility criteria:
inclusion criteria: * adult patients with hepatocellular (hcc) carcinoma receiving liver transplant exclusion criteria: * patients less than 18 years of age

Keywords: liver transplant hepatocellular carcinoma sirolimus
preliminary efficacy analysis of 'λ+α' double-tract reconstruction after laparoscopic proximal gastrectomy

Conditions: Gastric Cancer; Reflux Esophagitis

Summary: the incidence of proximal gastric cancer has increased significantly in recent years. this may be due to weight gain, alcohol consumption, gastroesophageal reflux disease (gerd), and precancerous lesions. with a deeper understanding of the pattern of lymph node metastasis and the emergence of anti-reflux procedures, proximal gastrectomy has gradually received clinical attention. for early-stage upper gastric cancer and esophagogastric combination cancer cases that are expected to have a good prognosis, the ideal surgical procedure should be to preserve the distal stomach to improve the quality of life and to choose a reasonable digestive tract reconstruction method to prevent reflux. the anti-reflux effect of various proximal gastrectomy digestive tract reconstruction methods and the advantages and disadvantages of various surgical procedures are controversial, and the recognized ideal reconstruction method has not yet been established. therefore, based on the stomach's anatomical features and the intercalated jejunum's anti-reflux mechanism, we propose a true dual-channel anastomosis for gi reconstruction, i.e., the "λ+α dual-channel anastomosis". this study aimed to investigate the efficacy and safety of proximal gastrectomy combined with "λ+α double-channel anastomosis" in the treatment of early gastric cancer.


Eligibility criteria:
inclusion criteria: age between 18-75 years old, male or female; pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer： ia and ib (t1n0m0, t1n1m0, and t2n0m0) (14) according to the eighth edition of the ajcc (15); no distant metastasis was observed on preoperative chest radiograph, abdominal ultrasound, or upper abdominal ct; asa grade 1-3; patients without contraindications to surgery; patients and their families voluntarily signed the informed consent form and participated in the study; exclusion criteria: patients diagnosed with primary tumors or distant metastasis; patients whose tumor is located in the greater curvature side of the stomach; patients with coagulation dysfunction that could not be corrected; patients who were diagnosed with viral hepatitis and cirrhosis; patients who were diagnosed with diabetes mellitus, uncontrolled or controlled with insulin; patients with organ failure such as heart, lung, liver, brain, and kidney failure; patients with ascites or cachexia preoperatively in poor general conditions; patients diagnosed with immunodeficiency, immunosuppression, or autoimmune diseases (such as allogeneic bone marrow transplant, immunosuppressive drugs, sle, etc.). patients refusing to sign the informed consent of the study;
application of the ice-t postoperative multimodal pain regimen to laparoscopic hysterectomy

Conditions: Pain, Postoperative

Summary: this is a randomized controlled trial evaluating whether application of ice packs and scheduled ketorolac to the surgical site after laparoscopic hysterectomy reduces need for narcotic medications.

patients who undergo laparoscopic hysterectomy and chose to participate in the study will be randomized to either receive the standard post-surgical analgesic protocol (control group) or the standard post-surgical analgesic protocol plus scheduled ketorolac and surgical site ice packs. usage of narcotic analgesics for breakthrough pain will be monitored and compared between cohorts. all care received by test subjects will be standard of care, with the only difference being the use of ice packs and scheduled ketorolac.

Eligibility criteria:
inclusion criteria: females, 18-65 years old at time of new patient evaluation, planned laparoscopic hysterectomy only or hysterectomy with or without unilateral or bilateral oophorectomy or salpingo-oophorectomy by dr. corey wagner, uterus with expected size greater than 250 grams as determined by bimanual exam or standard of care ultrasound obtained prior to or as part of new patient evaluation exclusion criteria: diagnosed or suspected endometriosis, diagnosis of malignant carcinoma of the uterus, ovaries, or fallopian tubes, diagnosis of severe renal disease (as determined by a gfr of less than 45), known nonsteroidal anti-inflammatory drug (nsaid) intolerance, history of myocardial infarction, stroke or other cardiovascular disease, known hypersensitivity or allergic reactions to acetaminophen, toradol, ibuprofen, other nsaids, aspirin or roxicodone, previous diagnosis of liver disease or hepatitis, unable to take tylenol (acetaminophen), pre-existing narcotic drug regimens or opioid use disorders, known diagnosis of or history of peptic ulcer disease, gastrointestinal bleeding or perforation, known or suspected gastrointestinal obstruction including paralytic ileus, diagnosis of severe bronchial asthma, known diagnosis or history of cerebrovascular bleeding, known bleeding disorder or coagulopathy based on patient history unless excluded by appropriate hematological examination, daily prescription nsaid use, adults unable to consent, pregnancy as determined by urine or serum pregnancy test obtained in women of child-bearing age, prisoners, individuals who do not read and understand english
team-based delivery of care in outpatient settings

Conditions: Chronic Disease

Summary: through this research we intend to evaluate whether a team-based care delivery approach using daily huddles is effective in improving caregiver and patient outcomes in primary care setting. this approach is expected to not only lead to effective primary care delivery outcomes, but also result in greater team morale, reduced burnout, and a higher rate of innovation.


Eligibility criteria:
inclusion criteria: * 18 year old adult * member of mayo care team in the midwest exclusion criteria: -unable to provide consent
effects of treatment of ascites by the alfapump system on renal and circulatory function

Conditions: Cirrhosis, Liver; Refractory Ascites

Summary: this is a single centre, prospective, uncontrolled study to include 12 consecutive patients with cirrhosis of the liver and recurrent or refractory ascites. the main aim (primary objective) of the study is to investigate the effect of treatment of ascites by the sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites. the secondary objectives are the following: * to evaluate the efficacy of treatment for handling ascites, associated with changes in the body weight of patients and their requirements for evacuation paracentesis during follow-up. * to investigate the effects of treatment on bacterial translocation, by means of determining bacterial dna. * to determine the incidence of complications associated with treatment in the course of follow-up. * to evaluate the effect of treatment on quality of life of the patients treated, evaluated in questionnaires entitled short form-36 and cldq (chronic liver disease questionnaire).


Eligibility criteria:
inclusion criteria: 1. patients \> 18 years of age 2. cirrhosis of the liver defined by histological and/or clinical, analytical and radiological criteria. 3. presenting refractory or recurrent ascites, requiring 2 or more evacuation paracentesis procedures over the last 3 months. 4. written informed consent 5. ability to comply with study procedures and ability to operate the device 6. women of childbearing age should use adequate contraceptives exclusion criteria: 1. digestive haemorrhage over the last 7 days (these patients can be included once the 7-day period has gone by). 2. kidney failure defined as serum creatinine higher than or equal to 2 mg/dl. 3. serum bilirubin greater than 5 mg/dl. 4. severe coagulopathy defined as platelet count of less than 40,000 or prothrombin time of less than 40%. 5. recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months. 6. recurring urinary infections, defined as 2 or more episodes over the last 6 months. 7. clinical evidence of loculated ascites. 8. advanced hepatocarcinoma, defined as one which exceeds milan criteria. 9. previous liver transplant. 10. obstructive uropathy or any bladder anomaly which might contraindicate implantation of the device. 11. pregnancy 12. patients being in another clinical study that did not reach primary endpoint yet